2005N-0345
  

  
 Drug Approvals:  Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC34
  



  

  
Submitter : 
  

  
Mr. Ralph Hudson
  

  
Date & Time: 
  

  
09/01/2005 04:09:59
  



  

  
Organization : 
  

  
Mr. Ralph Hudson
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
1
  


  

  



  

  
 A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?

  


  

  


  

  



  

  
 This question is asked twice in your webpage's form, with minor changes.  In response to either wording, it does not make sense that birth control pills require a doctor's prescription, while an abortifacient drug may potentially be made available to teenagers without a doctor's professional guidance.  An "active ingredient" is not being marketed for the same purpose in the case of the Plan B treatment, which is a high-dosage synthetic hormone treatment with the purpose of preventing implantation, not for the prevention of fertilization, which is the purpose of true birth control pills.  The only valid comparison for allowing an active ingredient to be simultaneously marketed in both a prescription drug product and an OTC drug product is when the exact same active ingredient is being used for the exact same medical reason, in the exact same dosage.  Allowing an abortifacient to be marketed OTC, while birth control pills require a doctor's prescription, simply because they both consist of the same synthetic hormone or combination of hormones (though in significantly different dosages) is disingenuous to the general public, by misrepresenting the completely different purposes for the drugs.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
1.
  


  

  



  

  
 A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?

  


  

  


  

  



  

  
 This question is asked twice in your webpage's form, with minor changes.  In response to either wording, it does not make sense that birth control pills require a doctor's prescription, while an abortifacient drug may potentially be made available to teenagers without a doctor's professional guidance.  An "active ingredient" is not being marketed for the same purpose in the case of the Plan B treatment, which is a high-dosage synthetic hormone treatment with the purpose of preventing implantation, not for the prevention of fertilization, which is the purpose of true birth control pills.  The only valid comparison for allowing an active ingredient to be simultaneously marketed in both a prescription drug product and an OTC drug product is when the exact same active ingredient is being used for the exact same medical reason, in the exact same dosage.  Allowing an abortifacient to be marketed OTC, while birth control pills require a doctor's prescription, simply because they both consist of the same synthetic hormone or combination of hormones (though in significantly different dosages) is disingenuous to the general public, by misrepresenting the completely different purposes for the drugs.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
  


  

  



  

  
 When the interpretation is potentially misused, as it may be in the case of the Plan B drug, there is significant confusion (or rather concern) about the true intentions and motivations behind the decision to allow an abortion drug to be made available to teenagers, based on the illogical comparison of the acts of preventing pregnancy with the act of preventing implantation of a fertilized egg.

  


  

  


  

  


  

  








  

  
C. If so, would a rulemaking on this issue help dispet that confusion?
  


  

  



  

  
It may dispel that confusion, if done correctly, but it will not "dispet" that confusion, as is written on your webpage.
  


  

  



  

  
2
  


  

  



  

  
 A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?

  


  

  


  

  



  

  
 This question requires a legal opinion, which is outside my qualifications.  My layman's opinion is that, in the overly-litigious American society in which we now live, it is inevitable that there will be lawsuits brought in protest of age discrimination, unless a significant medical reason exists for the limitation.

  


  

  


  

  


  

  


  

  
B. If it could, would it be able to do so as practical matter and, if so, how?
  


  

  



  

  
By the same methods currently used to enforce the separation of over-the-counter from prescriptions.
  


  

  



  

  
3
  


  

  



  

  
 A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?

  


  

  


  

  



  

  
Only if the goal is mass confusion and the complete breakdown of requiring that any drugs are dispensed only by a doctor's prescription.
  


  

  



  

  
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
  


  

  



  

  
Perhaps if the purpose is to terminate the life of an unborn child.